510(k) K946373
- Device
- MYCOPLASMA SLURRY AND MYCOPLASMA CROWNTITRE IFA TEST SYSTEM
- Applicant
- ZEUS SCIENTIFIC, INC.
- 510(k) number
- K946373
- Product code
- GRZ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1996-02-07
- Date received
- 1994-09-07
- Regulation
- 866.3375
- Classification name
- Antisera, Fluorescent, All, Mycoplasma Spp.
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- MARK J KOPNITSKY
- Address
- P.O.Box 38 Raritan NJ US 08869 08869
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code GRZ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K944417 | ZEUA MYCOPLASMA | Zeus Scientific, Inc. | 1995-08-01 |
| K931557 | FULLER LABORATORIES MYCOPLASM PNEUMONIA IFA-IGG TEST | Fuller Laboratories, Inc. | 1994-03-11 |
| K861716 | FIAX TEST KIT FOR MYCOPLASMA PNEUMONIAE-G ANTIBODY | Whittaker Bioproducts, Inc. | 1986-08-08 |
| K840012 | INDIRECT FLUORESCENT ANTIBODY MYCO | Zeus Technologies | 1984-02-27 |
Legacy Summary#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases
FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases